UPDATED: This post was updated for 2017 to reflect new information and more examples. Enjoy!
Electronic Data Capture (EDC) is an amazing tool for preclinical or animal labs. Because of the intricacies involved in conducting animal studies, it’s become increasingly important to use a system that was built around the workflow of a preclinical lab. Some of the more popular features offered by Clinical Studio make it an ideal tool for conducting preclinical studies. Here are just six features in Clinical Studio that make it an incredibly user-friendly tool for researchers who are designing and managing preclinical studies:
- Animal care is of great importance to preclinical labs. Keeping highly detailed, meticulous animal care records for each animal that is received by the lab is very important. With Clinical Studio, you can create the most detailed animal care forms and track animal care data for each animal from quarantine to study completion. Having those animal care records readily available and attached to the animal (through bar code or Animal ID) allows preclinical labs to instantly demonstrate their level of animal care.
- Clinical Studio can operate on the USDA calendar year. It can be configured to create animal IDs that are based on the USDA calendar year. You can configure any type of animal ID and keep your current animal ID convention. In addition, Clinical Studio is GCP and GLP compliant. If that is not enough, it is also Part 11 compliant. In fact, you can conduct human and animal trials in the same system with Clinical Studio. Those trials can be single site, multi-site or both.
- Using a naming convention when creating lab forms (such as blood or urine), Clinical Studio can be configured to read the electronic version of the lab report and import the lab data directly into the case report form without any human intervention. This allows you to analyze more data and eliminates the cost of data entry as well as the errors of data entry. This can be setup to pull from the central (or local) lab or have the lab push the data straight to Clinical Studio.
- Clinical Studio allows you to create roles and assign those roles access rights within the system. That means that preclinical labs can allow their sponsors limited access to their studies to monitor progress. The sponsors love this feature and are more likely to return for subsequent studies, both animal and human.
- Clinical Studio’s sister product, TrialKit, is a mobile app that supports 17 different bar code formats. Most animal suppliers will bar code the animal. In fact, some animals can have a code stamped right on them. Bar codes can be attached to the cage of the animal and go wherever the animal goes. To access the animal record, take out your iPhone or iPad (soon any Android device) and scan the code. TrialKit will go immediately to the animal’s record in the relevant study to which the animal belongs. For the daily checkup, this will bring up the electronic version of the daily checkup form. If an adverse event occurs, the electronic version of that form can be completed on the spot. Never again mix up animals and eliminate daily checkup and adverse event paper forms.
- Studies can be conducted completely on TrialKit, which is available on the App Store and soon on Google Play. That means all data can be captured point of care in real-time. This eliminates all paper within a study. Imagine a paperless study where the closeout documents are on a flash drive in the form of printable PDF documents! Completing CRFs on TrialKit is easier than paper or a browser based version of the CRF. With the shift from browser to mobile app, be ahead of the curve and eliminate paper.
The benefits don’t end here. Clinical Studio and TrialKit are fully-featured systems that puts you in complete control of all your studies. If you can use Microsoft Word, then you can create and manage your own studies. We will provide training at no additional cost and always be there to instantly provide an answer to any questions you may have, 24-7-365.
Clinical Studio costs $499/month for preclinical studies, which includes full access to the system (everything included above) and you’re free to create and host as many studies as you need. In addition, you can track non-study related items such as animal care and inventory. To learn more about how Clinical Studio can expedite and streamline your preclinical or animal lab studies, register for a product demonstration at a time that’s convenient for you.